Influence of Treatment for Patent Ductus Arteriosus on Cerebral Oxygenation in Preterm Infants

April 5, 2016 updated by: Manuel Schmid, University of Ulm

Changes of Cerebral Tissue Oxygen Saturation During Treatment of Patent Ductus Arteriosus in Neonates

The purpose of this study is to examine the influence medical or surgical treatment for patent ductus arteriosus in preterm infants on cerebral and renal tissue oxygenation and on cardiac output.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this observational trial the investigators want to examine whether clinical or echocardiographic parameters of patent ductus arteriosus are related to

  • cerebral tissue oxygen saturation, total hemoglobin, fractional tissue oxygen extraction and HbD
  • renal tissue oxygen saturation, total hemoglobin, fractional tissue oxygen extraction and HbD

as measured by near infrared spectroscopy

and to

  • stroke volume
  • cardiac output

as measured by electrical cardiometry.

The investigators want to examine the impact of surgical and medical treatment for patent ductus on these parameters. The investigators want to compare the change of these parameters between responders to medical treatment and nonresponders.

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Ulm, Baden-Württemberg, Germany, 89075
        • University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Preterm neonates with patent ductus arteriosus treated in our hospital

Description

Inclusion Criteria:

  • Newborn infant below 34 weeks postmenstrual age at the time of birth
  • Patent ductus arteriosus with signs of hemodynamic relevance (as judged by the attending neonatologist)
  • parental informed consent

Exclusion Criteria:

  • Patent ductus arteriosus as part of malformation syndrome
  • Additional major cardiovascular malformations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Indomethacin
Infants treated with Indomethacin
Drug: Indomethacin
3 doses of 0,2mg/kg every 12h (first week of life) or every 8h (after first week of life)
Ibuprofen
Infants treated with Ibuprofen
Drug: Ibuprofen
3 doses every 24h; first dose 10mg/kg, second and third dose 5mg/kg
Ligation
Infants undergoing surgical ligation
Procedure: Surgical Ligation
In nonresponders to medical treatment with persistent hemodynamically relevant patent ductus arteriosus surgical ligation is performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of cerebral tissue oxygen saturation during treatment for patent ductus arteriosus
Time Frame: from 10 minutes before start of infusion until 4 hours after end of transfusion
from 10 minutes before start of infusion until 4 hours after end of transfusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

August 31, 2011

First Submitted That Met QC Criteria

September 1, 2011

First Posted (Estimate)

September 2, 2011

Study Record Updates

Last Update Posted (Estimate)

April 6, 2016

Last Update Submitted That Met QC Criteria

April 5, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULMNEONIRS03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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